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Local Anesthetic

Ropivacaine for Postoperative Pain in Sports Injuries

Phase 2

Waitlist Available

Led By Philip Wilson, MD

Research Sponsored by Texas Scottish Rite Hospital for Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

10+ years old

Presenting with an injury that requires an ACL reconstruction with a bone-patellar tendon-bone or quadriceps tendon graft

Must not have

Patients <10 years old

Injury requires fracture repair or another non-standardized surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperatively and within one week postoperatively.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if giving a single-shot ropivacaine nerve block during ACL reconstruction surgery in young sports medicine patients can help reduce pain and the need for pain medication. They want to know

Who is the study for?

This trial is for pediatric patients undergoing ACL reconstruction surgery. It's designed to see if a single-shot nerve block with ropivacaine can help manage pain after the operation and reduce the need for narcotics.

What is being tested?

Researchers are testing whether a one-time injection of ropivacaine, given during surgery, can lower pain levels and decrease narcotic use post-surgery compared to not using the nerve block. Participants will report their pain and medication use over a week.

What are the potential side effects?

Ropivacaine may cause side effects such as weakness or numbness near the injection site, nausea, low blood pressure, or an allergic reaction. However, it's generally considered safe with proper medical supervision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 10 years old.

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I need ACL surgery using a tendon from my knee or thigh.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 10 years old.

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I need surgery for a fracture or another specific injury.

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My ACL reconstruction will use a graft type that is not bone-patellar tendon-bone or quadriceps tendon.

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I need surgery for a leg injury that isn't mainly for an ACL repair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative days 1, 4, and 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative days 1, 4, and 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative days 1, 4, and 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Management Patient Satisfaction questionnaire

Scottish Rite for Children-developed pain questionnaire

Visual Analog Scale (VAS) 10-centimeter line 0-10 Numeric Pain Intensity Scale

+1 more

Secondary study objectives

Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Scale v1.0 - Global Health 7+2

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Peripheral Nerve Block (PNB) groupActive Control1 Intervention

* Patients will receive a purple surgical marker dot at the decided site of injection * A 20 mL Adductor PNB will be injected intraoperatively at the point of the purple dot * Patient will receive 0.2% plain Ropivacaine (perineural injection) regardless of weight

Group II: No Peripheral Nerve Block (PNB) groupActive Control1 Intervention

* Patients will receive a purple surgical marker dot at a point where a PNB would be injected, if they were randomized to the no peripheral nerve block group * A bandage will be placed over the purple dot and wrapped with the standard gauze/bandage from the surgery

0 / 6Eligibility criteria met